ADVIL 200 MG TABLETS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
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Active ingredient:
IBUPROFEN
Available from:
Pfizer Consumer Healthcare Ltd
Dosage:
200 Milligram
Pharmaceutical form:
Coated Tablets
Authorization date:
1997-10-31
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0172/029/001
Case No: 2086521
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
PFIZER CONSUMER HEALTHCARE LTD
RAMSGATE ROAD, SANDWICH, KENT, CT13 9NJ, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
ADVIL 200 MG TABLETS
the particulars of which are set out in the attached Schedule. The authorisation is also subject to the general conditions as may be specified in
the said Regulations as listed on the reverse of this document.
This authorisation, unless previously revoked, shall continue in force from 28/07/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 28/07/2010_
_CRN 2086521_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Advil 200 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Ibuprofen 200 mg.
Excipients: Also contains sucrose, methyl parahydroxybenzoate (E 218) + propylparahydroxybenzoate (E 216)
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Coated tablet (tablet)
A pinkish brown, sugar coated tablet with ‘Advil’ printed in black on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short term management of pain and fever conditions such as:
Acute pain from dysmenorrhoea.
Dental pain.
Muscular pain.
Headaches.
Colds and flu symptoms.
Backache.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults, the elderl
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